Obligations of distributors and importers concerning repackaging and labeling of medical devices
Article 16 MDR identifies cases where the manufacturer’s obligations also apply to importers, distributors and other persons
Importers and distributors may have manufacturing obligations in accordance with Article 16 MDR in certain cases. For details, see our previous news (focus on importers, applies accordingly to distributors). The following are cases from Article 16(2) MDR
- involving the change of the outer packaging of a product already on the market, including the change of package size and relabeling, as well as
- the provision of information for use, including translation into the language of the member state.
Importers and distributors must ensure that these activities are carried out under conditions that guarantee that the original condition of the products cannot be affected as a result.
Article 16(3) of the MDR therefore requires that distributors and importers “have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned [above] are performed by a means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy.”
In accordance with Article 16(4) MDR, a corresponding quality management system of importers and distributors must be certified by a notified body.
Guidance document MDCG 2021–23
In practice, this requirement poses particular challenges for a large number of importers and distributors, but also for notified bodies. There was speculation and discussion about the setting and scope of the required quality management system on the one hand, the inspection contents of the notified bodies and the minimum details of the certificates to be issued by them. With the MDCG 2021–23 guidance document (PDF) the Medical Device Coördination Group (MDCG) has set itself the goal, among other things, of showing importers and distributors the minimum requirements for a QM system required of them.
Minimum requirements for a QM system of distributors and importers
The minimum requirements for an appropriate QM system are stated in MDCG 2021–23:
- documentation of the management system,
- Resource management, including premises and equipment necessary to carry out activities referred to in Article 16(2)(a) and (b) MDR, as well as selection and control of suppliers and sub-contractors,
- policies for assignment of activities and responsibilities to personnel ensuring the availability of resources and information necessary to support the operation and monitoring of the activities mentioned,
- procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with the Regulation,
- management of corrective actions including procedures for handling non-conforming devices and market recalls due to the activities carried out under Article 16(2)(a) and (b), including, when necessary, field safety corrective actions and verification of their effectiveness,
- procedures to ensure traceability of the devices as well as labels, instructions for use and outer packaging indicating the changes made to the product,
- control of documents,
- control of records,
- supervision of the implementation and maintenance of the quality management system.
Overall, the quality management system should be capable of supporting and demonstrating the consistent achievement of the requirements of Article 16(3) MDR.
Impact on contract design
In addition, by highlighting the necessary contractual arrangements, the MDCG sheds light on another point that is essential for economic actors to coöperate with each other. It emphasises that information requirements should also be included in importers’ and distributors’ contracts with manufacturers of the products to ensure that the distributor or importer is informed in a timely manner of any corrective action taken by the manufacturer with respect to the relevant product to address safety issues or bring the product into compliance with the Regulation. In addition, the contract between the notified body and the distributor or importer should provide for the possibility of the notified body being authorised to conduct on-site audits at the premises of the distributors and importers themselves, but also at their subcontractors.
Recommendation for action
Guidance documents of the MDCG are, as the name suggests, recommendations or guidelines; they are not legally binding. Nevertheless, as the recommendation from a group of experts, they provide valuable support for economic actors when it comes to implementing the MDR requirements.
The requirements for the QM system at importers and distributors are new; notified bodies are scarce and busy and also confronted with the “new” regulations. In order to pass an audit quickly and without deviations, importers and distributors are therefore well advised to deal with the contents of Article 16 MDR and to follow the recommendations of the MDCG with regard to the implementation and scope of a quality management system. The same applies to the inclusion of the (from the MDCG’s point of view) particularly relevant information obligations and on-site audit option in contracts with manufacturers and notified bodies.